Device for extending a length of a penile implant

ABSTRACT

A device for extending a length of a penile implant includes a bellows segment and a bevels segment. The bellows segment has a hollow body portion and a rounded tip portion, with the body portion including a circumferential wall having a plurality of internal grooves and an aperture adjacent and perpendicular to the internal grooves. The bevels segment has a protrusion configured to spirally rotate to engage with the plurality of internal grooves of the bellows segment and lock into place within the at least one aperture.

BACKGROUND

Penile protheses offer men suffering from erectile dysfunction with anerection that is suitable for penetrative intercourse. A variety oftreatment options exist for erectile dysfunction patients includingimplants. Implants may include a self-contained, fluid-filled system andmay include extenders to tailor implants to the appropriate sizingrequirements and/or to assist with exit tubing angle. However, surgeonshave found conventional hollow rear tip extenders (RTE) problematic inthat they negatively affect axial loading and may be insecurelyattached. A problem associated with hollow RTE's is that the pivotpoint, having the highest load, is moved anteriorly toward the head ofthe penis. As a result, portions of hollow RTE's have been known to snapoff and cause penile instability during use causing discomfort andembarrassment to the patient. Therefore, an alternate RTE is desired.

SUMMARY

Various aspects of the present disclosure are directed toward devices,systems, and methods for extending of a penile implant protheses. Thedevices, systems, and methods may include a support segment, a receivingsegment, and at least one extension segment for securing the device at adesired extension distance to the penile implant protheses. The supportsegment may have a tip portion and a threaded portion. The receivingsegment may be coupled to a distal end of the penile implant. Thereceiving segment may be configured to rotatably receive the threadedportion to secure the support segment to the penile implant. The atleast one extension segment may be configured to at least partiallysurround the threaded portion to extend a length between the tip portionand the penile implant. The at least one extension segment may comprisea plurality of extension segments. The plurality of extension segmentsmay include a first extension segment of a first length and a secondextension segment of a second length, wherein the first length isdifferent from the second length. The first extension segment may bearranged at the distal end of penile implant and the second extensionsegment is arranged between the first extension segment and the tipportion. The plurality of extension segments may include three extensionsegments configured to at least partially surround the threaded portion.The tip portion may include a rounded shape contoured according to thedistal end of the penile implant. The support segment may comprise abiopolymer material. The at least one extension segment may comprise abiopolymer material. The at least one extension segment may besubstantially cylindrical.

Various aspects of the present disclosure are also directed towarddevices, systems, and methods that may include an extension deviceincluding a bellows segment and a bevels segment. The bellows segmentmay have a hollow body portion and a rounded tip portion. The bodyportion may include a circumferential wall having a plurality ofinternal grooves and at least one aperture adjacent and perpendicular tothe internal grooves. The bevels segment may have at least oneprotrusion configured to spirally rotate to engage with the plurality ofinternal grooves of the bellows segment and lock into place within theat least one aperture. The at least one aperture may include a pair ofapertures disposed 180 degrees apart, the pair of apertures adjacent andperpendicular to the internal grooves. The circumferential wall mayinclude at least two pairs of apertures offset longitudinally andconfigured to facilitate different desired extension distances. Therounded tip portion may include a shape contoured according to thedistal end of the penile implant. The bellows segment may comprise abiopolymer material. The bevels segment may comprise a biopolymermaterial.

Various aspects of the present disclosure are also directed towarddevices, systems, and methods that may include an extension deviceincluding a support segment having a tip portion, a threaded portion,and an expandable bellows segment. The expandable bellows segment isarranged between the tip portion and the threaded portion. The tipportion includes a port configured to receive a fluid for expanding theexpandable bellows segment. The threaded portion is configured to matewith a receiving segment coupled to a distal end of the penile implant.The receiving segment may be configured to rotatably receive thethreaded portion to secure the support segment to the penile implant.The expandable bellows segment may be configured to facilitate desiredextension distances. The tip portion may include a rounded shapecontoured according to the distal end of the penile implant. The supportsegment may comprise a biopolymer material. The support segment may beof one-piece construction.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a screw in adjustable rear tip extenderdevice, according to some embodiments.

FIG. 2 illustrates a detailed view of the support member of FIG. 1.

FIG. 3 illustrates an exploded view of extension segments of FIG. 1.

FIG. 4 is a perspective view of click lock rear tip extender device,according to some embodiments.

FIG. 5 illustrates a detailed view of the bellows segment of FIG. 4.

FIG. 6 illustrates a cross-sectional view, rotated 90 degrees, of thebevels segment of FIG. 4.

FIG. 7 is a schematic view of another screw in adjustable rear tipextender device having an expandable bellows segment in an expandedconfiguration, according to some embodiments.

FIG. 8 illustrates the screw in adjustable rear tip extender as in FIG.7 in an unexpanded configuration.

While the invention is amenable to various modifications and alternativeforms, specific aspects have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular aspects described. On thecontrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DESCRIPTION

Various aspects of the present disclosure are directed towardimplantable medical devices for the treatment of male erectiledysfunction. Surgical implantation of prostheses may include penileimplants. In certain implant procedures, the implant includes anextension device in order to appropriately size the device to thepatient. The extension devices, consistent with various aspects of thepresent disclosure, may be capable of extending an implant for erectiledysfunction to the desired extension distance.

FIG. 1 illustrates an extension device 100, according to someembodiments. Device 100 is an adjustable rear tip extender device. Asshown in FIG. 1, the device 100 includes a support segment 200, aplurality of extension segments 300, and a receiving segment 400insertable within the distal end 50 of penile implant 10. Receivingsegment 400 of device 100 may be a screw in feature for attachment ofdevice 100 to the distal end 50 of a penile implant 10. The extensionsegments 300 may include an open central bore or area as shown.

As shown in FIG. 1, support segment 200 has a tip portion 220, an endportion 260 (shown in FIG. 2), and a threaded portion 240 between thetip portion 220 and the end portion 260. Tip portion 220 includes arounded shape contoured according to the distal end 50 of the penileimplant 10 so that the penile implant 10 and device 100 combination hasa smooth external surface. The smooth external surface of the tipportion 220 allows device 100 to seamlessly take the place of the end(not shown) of the penile implant 10. The smooth design of tip portion220 allows for easier insertion. Tip portion 220 is solid and thus thepivot point will not be altered by the addition of device 100 to penileimplant 10, therefore, the stability of the penile implant 10 isuncompromised. As shown in FIG. 2, end portion 260 may be blunt, inother words, a smooth surface free of sharp corners or edges. Advantagesof the smooth surface of the end portion 260 include ensuringinjury-free insertion by the surgeon while also ensuring that the penileimplant 10 will not be damaged during insertion.

The device 100 is adjustable to a desired extension distance D₁according to the number and/or width of the extension segments 300loaded onto the support segment 200. In other words, one, two, three, ormore extension segments 300 may at least partially surround or encirclethe support segment 200 in order to achieve a desired extension distanceD₁. As shown in FIG. 3, each extension segment 300 may have a differentlength, e.g., segment 310 having a first length L₁, segment 320 having asecond length L₂, segment 330 having a third length L₃. Therefore, theextension distance D₁ is adjustable according to whether the segment 310and/or segment 320 and/or segment 330 is loaded onto the support segment200. The device 100 may be used, for example, to provide a prosthesishaving a desired length that is appropriate to the patient. In certaininstances, additional hollow extension segments 300 than the ones shownmay be included to further adjust the length as desired.

In some embodiments, the support segment 200 having tip portion 220 atip length, L_(t), contributes also to the extension distance D₁. In anon-limiting example, length L_(t) contributes 0.5 cm to the extensiondistance D₁. Each segment adds as needed, e.g., in a non-limitingexample, segment 310 having length L₁ of 0.5 cm, segment 320 havinglength L₂ of 1.0 cm, and segment 330 having length L₃ of 1.5 cm.Segments 310, 320, and 330 are added so that the extension distance D₁ranges from about 0.5 cm including length L_(t) only to about 3.5 cmwith the three segments 310, 320, and 330 added. In some embodiments,any number of extension segments 300 (e.g., 310, 320, 330) are used asdesired. In various embodiments, extension segments 300 may each be ofthe same width or of different widths as in the non-limiting exampleabove.

As shown in FIG. 1, receiving segment 400 is disposed at the distal end50 of the penile implant 10. Receiving segment 400 is coupled to thesupport segment 200 by rotating the support segment 200 into thereceiving segment 400 to secure the device at a desired extensiondistance D₁. Threaded portion 240 includes a plurality of threads 250.Receiving segment 400 includes a hole 420, and the hole 420 including aplurality of internal grooves 440. Internal grooves 440 (shown inFIG. 1) are configured to matingly receive the plurality of the threads250 (shown in FIG. 3) to secure the support segment 200 at the desiredextension distance D₁.

Device 100 is attached to a penile implant 10 at the distal end 50 viareceiving segment 400. Device 100 works by being screwed into the backof the penile implant 10. Moreover, device 100 includes the non-hollowsupport segment 200 to provide greater strength along the extensiondistance D₁. Device 100 may be advantageously safer and more stable thanother RTE designs, which were hollow and prone to failure by snappingoff due to the pivot point moving anteriorly toward the head of thepenis.

Support segment 200 and/or extension segments 300 and/or receivingsegment 400 of the device 100 may include any suitable medical gradematerial. Examples of such materials include various biopolymer, and/orother various biologically compatible materials. In preferred instances,the biopolymer material is hydrophilic. In certain instances, thesupport segment 200 may be Bioflex®. In certain instances, the extensionsegments 300 may be a Bioflex®. In certain instances, the receivingsegment 400 may be a Bioflex. FIG. 4 illustrates an extension device500, according to other embodiments. Device 500 may include a click lockrear tip extender device for extending a penile implant. The device 500includes a bellows segment 600 and a bevels segment 700. As illustratedin the cross-sectional view of bellow segment 600 in FIG. 5, bellowssegment 600 has a hollow body portion 620 and a rounded tip portion 660.In some embodiments, the rounded tip portion 660 includes a shapecontoured according to the distal end of the penile implant. In someembodiments, the tip portion 660 may be solid.

As shown in FIG. 5, the hollow body portion 620 includes acircumferential wall 630 having a plurality of internal grooves 640. Thecircumferential wall 630 further includes at least one aperture 650through the circumferential wall 630. The at least one aperture 650 isadjacent and perpendicular to an internal groove 640. In someembodiments, the at least one aperture 650 may include a shape, such asa circular or rectangular shape. In some embodiments, thecircumferential wall 630 includes a pair of apertures 655 disposed 180degrees apart (as shown in FIG. 4). Each of the apertures 650 in thepair of apertures 655 is adjacent and perpendicular to an internalgroove 640. In yet other embodiments, the circumferential wall 630includes at least two pairs of apertures 655 with each pair of apertures655 offset longitudinally and configured to facilitate different desiredextension distances D₂. As shown in FIG. 5, each aperture 650 is offsetlongitudinally. In various embodiments, circumferential wall 630 mayinclude three pairs of apertures 655, or four pairs of apertures 655, ormore, with each pair of apertures 655 offset longitudinally to allowadjusting the device 500 to a desired extension distances D₂.

As shown in FIGS. 4 and 6, bevels segment 700 includes a plurality ofexternal bevels 720 in a first portion 740 for mating with a distal endof a penile implant (not shown). The bevels segment 700 includes atleast one protrusion 760 in a second portion 780. The at least oneprotrusion 760 is spirally rotatable to engage with the plurality ofinternal grooves 640 of the bellows segment 600 and lock into placewithin the at least one aperture 650. The at least one protrusion 760may be clicked or locked into place to the at least one aperture 650when aligned at a desired extension distance D₂. In some embodiments,the at least one protrusion 760 may include a shape, such as a circularor rectangular shape, to matingly engage with the at least one aperture650. In some embodiments, portion 780 includes a pair of protrusions765, which may be clicked or locked into place to a pair of apertures655 when aligned at a desired extension distance D₂.

In certain instances, the aperture(s) 650 may have dimensions differentfrom the protrusion(s) 760 to facilitate a snap fit. In certaininstances, the protrusion(s) 760 of bevels segment 700 are disengagedfrom the bellow segment 600 to adjust the distance D₂ and then reengagedby mating the protrusion(s) 760 to another longitudinally offsetaperture 650 or pair of apertures 655.

Bellows segment 600 and/or bevels segment 700 of the device 500 mayinclude any suitable medical grade material. Examples of such materialsinclude various biopolymer, and/or other various biologically compatiblematerials. In certain instances, the bellows segment 600 may beBioflex®. In certain instances, the bevels segment 700 may be aBioflex®.

FIG. 7 illustrates an extension device 800, according to someembodiments. Device 800 is another adjustable rear tip extender device.As shown in FIG. 7, the device 800 includes a support segment 900 havinga tip portion 920, a threaded portion 940, and an expandable bellowssegment 960. Expandable bellows segment 960 is arranged between the tipportion 920 and the threaded portion 940. Expandable bellows segment 960is hollow. Threaded portion 940 includes a plurality of threads 950.

As shown in FIG. 7, the tip portion 920 further includes a port 980configured to receive a fluid F. Fluid F may include biomedicallycompatible fluids such as. Fluid F is injected into port 980 via adelivery apparatus 1000, which may be a syringe. As fluid F is injectedor otherwise delivered into port 980, fluid F passes through tip 920 andis received by the expandable bellows segment 960. As fluid F is filledinto the expandable bellows segment 960, into the expandable bellowssegment 960 is elongated to expand longitudinally to a desired distance.Advantageously, device 800 is expandable to any desired distance from aninitial unexpanded configuration D_(i), having no fluid F in expandablebellows segment 960, to a final fully expanding configuration D_(f),having expandable bellows segment 960 fully loaded with fluid F tomaximum capacity. FIG. 7 shows expandable bellows segment 960 in anexpanded configuration providing a desired distance D₃. Support segment900 of FIG. 7 is shown in FIG. 8 in an unfilled, unexpandedconfiguration providing a distance D₄, wherein distance D₃ is less thandistance D₄. Because device 800 may provide any desired distance betweenan initial (unexpanded) distance D_(i) a final (fully expanded) distanceD_(f), advantageously the desired distance may be tailored to thepatient without requiring additional components.

Receiving segment (not shown) of device 800 may be a screw in featurefor attachment of device 800 to the distal end 50 of a penile implant 10(similarly as shown in FIG. 1 for device 100 having receiving segment400). For example, receiving segment 940 may be coupled to a distal endof the penile implant. The receiving segment is configured to rotatablyreceive the threaded portion 940 having plurality of threads 950 tosecure the support segment 900 to the penile implant 10.

Support segment 900 may be of one-piece construction. Support segment900 or any portion thereof, including tip portion 920, threaded portion940, and expandable bellows segment 960, of the device 800 may includeany suitable medical grade material. Examples of such materials includevarious biopolymer, and/or other various biologically compatiblematerials. In preferred instances, the biopolymer material ishydrophilic. In certain instances, the support segment 900 may beBioflex®. In certain instances, the tip portion 920 may be a Bioflex®.In certain instances, the threaded portion 940 may be a Bioflex. Incertain instances, the expandable bellows segment 960 may be a Bioflex.In some embodiments, the rounded tip portion 920 includes a shapecontoured according to the distal end of the penile implant. In someembodiments, the tip portion 920 may be solid and substantiallyencircling port 980.

As the terms are used herein with respect to ranges of measurements(such as those disclosed immediately above), “about” and “approximately”may be used, interchangeably, to refer to a measurement, position, orarrangement, that includes the stated measurement, position, orarrangement and that also includes any measurement, positions, orarrangements that are reasonably close to the stated measurement,position, or arrangement, but that may differ by a reasonably smallamount such as will be understood, and readily ascertained, byindividuals having ordinary skill in the relevant arts to beattributable to measurement error, differences in measurement and/ormanufacturing equipment calibration, human error in reading and/orsetting measurements, positions, or arrangements, adjustments made tooptimize performance and/or structural parameters in view of differencesin measurements, positions, or arrangements associated with othercomponents, particular implementation scenarios, imprecise adjustmentand/or manipulation of objects by a person or machine, and/or the like.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

What is claimed is:
 1. A device for extending a length of a penileimplant, the device comprising: a bellows segment having a hollow bodyportion and a rounded tip portion, the hollow body portion including acircumferential wall having a plurality of internal grooves and at leastone aperture adjacent and perpendicular to each of the plurality ofinternal grooves; and a bevels segment having at least one protrusionconfigured to spirally rotate to engage with one of the plurality ofinternal grooves of the bellows segment and lock into place within theat least one aperture.
 2. The device of claim 1, wherein the at leastone aperture includes a pair of apertures disposed 180 degrees apart,the pair of apertures adjacent and perpendicular to each of theplurality of internal grooves.
 3. The device of claim 2, wherein thecircumferential wall includes at least two pairs of apertures offsetlongitudinally and configured to facilitate desired extension distances.4. The device of claim 1, wherein the rounded tip portion includes ashape contoured according to the distal end of the penile implant. 5.The device of claim 1, wherein the bellows segment comprises abiopolymer material.
 6. The device of claim 1, wherein the bevelssegment comprises a biopolymer material.
 7. A device for extending apenile implant, the device comprising: a support segment having a tipportion, a threaded portion, and an expandable bellows segment arrangedbetween the tip portion and the threaded portion; the tip portion havinga port configured to receive a fluid for expanding the expandablebellows segment; and a receiving segment coupled to a distal end of thepenile implant, the receiving segment configured to rotatably receivethe threaded portion to secure the support segment to the penileimplant.
 8. The device of claim 7, wherein the expandable bellowssegment is configured to facilitate desired extension distances.
 9. Thedevice of claim 7, wherein the tip portion includes a rounded shapecontoured according to the distal end of the penile implant.
 10. Thedevice of claim 7, wherein the support segment comprises a biopolymermaterial.
 11. The device of claim 7, wherein the support segment is ofone-piece construction.